Good Manufacturing Practice (GMP) News
Revision of European Commission Guideline on Good Manufacturing Practice for Medicinal Products
The European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.
Stakeholders are invited to comment on this draft by 31st May 2014 at the latest.
The PIC/s Guides to GMP
The PIC/s Guide to GMP have been updated. Of particular interest is the change to Chapter 4 on documentation which extends slightly on the EU GMPs that were updated in June 2011.
Qualified Persons (QPs) please take note!
The EMA Draft Reflection Paper on use of interactive voice response (IVR) technology to justify not including reanalysis/expiry dating on the label for clinical supplies is proposing yet another task for the QP, please see the link below; the last date for comments is 15th February 2012.
For those involved in advanced therapy medicinal products (ATMPs)
A reminder that EMA has issued a Committee for Medicinal Products for Human Use (CHMP)/Committee for Advanced Therapies (CAT) position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products, effective June 2011. See link below.
EC concept paper on the requirement for safety features in line with the falsified medicines legislation
The European Commission has issued a concept paper which has been published for consultation. Comments and suggestions are invited by 27th April 2012
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Good Laboratory Practice for Nonclinical Laboratory Studies
The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System.